LegalizeCommission Implementing Regulation (EU) 2021/552 of 30 March 2021 granting a Union authorisation for the biocidal product family ‘DEC-AHOL® Product Family’ (Text with EEA relevance)
Article 1
A Union authorisation with authorisation number EU-0024324-0000 is granted to Veltek Associates Inc. Europe for the making available on the market and use of the biocidal product family ‘DEC-AHOL® Product Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 20 April 2021 until 31 March 2031.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
DEC-AHOL® Product Family
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Authorisation number EU-0024324-0000
R4BP asset number EU-0024324-0000
PART I.
FIRST INFORMATION LEVEL
| Name | DEC-AHOL® Product Family |
|---|---|
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Rozengaard 1940 8212DT Lelystad NL |
| Authorisation number | EU-0024324-0000 |
| R4BP asset number | EU-0024324-0000 |
| Date of the authorisation | 20 April 2021 |
| Expiry date of the authorisation | 31 March 2031 |
| Name of manufacturer | Veltek Associates, Inc., |
| --- | --- |
| Address of manufacturer | 15 Lee Blvd. PA19355 Malvern United States (the) |
| Location of manufacturing sites | 15 Lee Blvd. PA19355 Malvern United States (the) |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Exxon Mobil Chemical Company |
| Address of manufacturer | 4045 Scenic Hwy, Baton Rouge, LA 70805 Louisiana United States (the) |
| Location of manufacturing sites | Exxon Mobil Chemical Company site 1 4045 Scenic Hwy, Baton Rouge, LA 70805 Louisiana United States (the) |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Monument Chemical Houston, LTD |
| Address of manufacturer | 16717 Jacintoport Boulevard 77015 Houston United States (the) |
| Location of manufacturing sites | Monument Chemical Houston, LTD site 1 16717 Jacintoport Boulevard 77015 Houston United States (the) |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Shell Chemicals |
| Address of manufacturer | 150 St Claire Parkway ON N0N 1G0 Corunna Canada |
| Location of manufacturing sites | Shell Chemicals site 1 150 St Claire Parkway ON N0N 1G0 Corunna Canada |
| Common name | IUPAC name |
| --- | --- |
| Propan-2-ol | |
| Formulation type(s) | AE Aerosol dispenser AL Any other liquid XX others - RTU wipe |
| --- | --- |
PART II.
SECOND INFORMATION LEVEL - META SPC(S)
| Identifier | Meta SPC: Meta SPC 1 |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| --- | --- |
| Common name | IUPAC name |
| --- | --- |
| Propan-2-ol | |
| Formulation type(s) | XX other - RTU wipe |
| --- | --- |
| Hazard statements | H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P280: Wear protective gloves. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. P501: Dispose of contents to in accordance with local/national regulations. P280: Wear eye protection. |
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: - Scientific name: no data Common name: yeast Development stage: - |
| Field(s) of use | indoor use Disinfectant wipe for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs. |
| Application method(s) | Method: Wiping of surfaces Detailed description: - |
| Application rate(s) and frequency | Application rate: - Dilution (%): RTU Number and timing of application: Product may be used multiple times a day, if required. Contact time: 2 min Individual wipes: 15.2 cm x 15.2 cm wipe - 4 wipes per m2 30.5 cm x 30.5 cm wipe - 1 wipe per m2 45.7 cm x 45.7 cm wipe - 1 wipe per m2 Multi pack wipes: 23 cm x 23 cm - 2 wipes per m2 30.5 cm x 30.5 cm - 1 wipe per m2 |
| Category(ies) of users | industrial |
| Pack sizes and packaging material | Pre-saturated 65.4% w/w propan-2-ol and water for injection (WFI) wipes. Individual wipes A wipe is composed of 100% continuous filament polyester fibre. The wipes are packaged in individual heat-sealed plastic bags made of low density polyethylene. Pack sizes: 15.2 cm x 15.2 cm wipe - 100/case, non- sterile 15.2 cm x 15.2 cm wipe - 100/case, sterile 30.5 cm x 30.5 cm wipe - 100/case, sterile 45.7 cm x 45.7 cm wipe - 100/case, sterile Multi pack wipes A wipe is composed of 100% continuous filament knitted polyester fibre; 20 wipes per pack; folded together in a re-closable bag package. Pack sizes: 100% polyester 30.5 cm x 30.5 cm wipe - 200/case, non-sterile 100% polyester 30.5 cm x 30.5 cm wipe - 200/case, sterile 100% polyester 23 cm x 23 cm wipe - 200/case, sterile |
Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to Good Manufacturing Practice (GMP) EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Only use wet wipes. Remove one or two wipes at a time for individual wipes and one wipe at a time for multipack wipes. Make sure to wet surfaces completely. Allow to take effect for at least 2 minutes. Discard wipe after use in a closed container and for multipack wipes close the package after opening.
Individual wipes:
Multi pack wipes:
See general directions for use
See general directions for use.
See general directions for use.
See general directions for use.
See use-specific instructions for use.
Use adequate ventilation with an air change rate of 8 per hour or more.
Apply away from eyes and face.
Hand protection: Wear chemically resistant protective gloves.
Eye protection: Wear eye protection.
Avoid contact with eyes.
Do not breathe vapours.
Do not eat, drink or smoke when using the product.
Wash hands thoroughly after handling.
Symptoms/injuries after inhalation : May cause drowsiness or dizziness
Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
Symptoms/injuries after eye contact: Causes serious eye irritation
Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Rinse skin with water/ or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor
IF SWALLOWED: Rinse mouth. Give something to drink if conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
Empty containers must be discharged as normal waste or recycled where possible.
Additional information: Handle empty containers with care because residual vapours are flammable.
Keep container tightly closed. Keep in a cool, well-ventilated place. Keep away from open flames, hot surfaces and sources of ignition. Store at temperatures below 30°C.
Shelf-life: 3 years
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
| Trade name(s) | ALCOH-WIPE® | Market area: EU | |||
|---|---|---|---|---|---|
| PROCESS2WIPE® IPA70 | Market area: EU | ||||
| Authorisation number | EU-0024324-0001 1-1 | ||||
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | active substance | 67-63-0 | 200-661-7 | 65,4 | |
| Identifier | Meta SPC: Meta SPC 2 | ||||
| --- | --- | ||||
| Number | 1-2 | ||||
| --- | --- | ||||
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals | ||||
| --- | --- | ||||
| Common name | UPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Propan-2-ol | active substance | 67-63-0 | 200-661-7 | 64,8 - 64,8 % (w/w) | |
| Formulation type(s) | AE Aerosol dispenser | ||||
| --- | --- | ||||
| Hazard statements | H222 : Extremely flammable aerosol, H229 : Pressurised container: May burst if heated H229: Pressurised container: May burst if heated H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. | ||||
| --- | --- | ||||
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P211: Do not spray on an open flame or other ignition source. P251: Do not pierce or burn, even after use. P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P280: Wear protective gloves. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. P410+P412: Protect from sunlight. Do no expose to temperatures exceeding 50°C/ 122°F. P501: Dispose of contents to in accordance with local/national regulations. P280: Wear eye protection. | ||||
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals | ||||
| --- | --- | ||||
| Where relevant, an exact description of the authorised use | - | ||||
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: - Scientific name: no data Common name: yeast Development stage: - | ||||
| Field(s) of use | indoor use Disinfectant for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs. | ||||
| Application method(s) | Method: Aerosol spraying on surfaces Detailed description: - | ||||
| Application rate(s) and frequency | Application rate: Maximal application 35 ml/m2 Dilution (%): RTU Number and timing of application: Product may be used multiple times a day, if required. Apply product by spraying from 15-20 cm distance for 20 seconds/m2. Contact time: 1 minute | ||||
| Category(ies) of users | industrial | ||||
| Pack sizes and packaging material | 325 ml (11 oz) - aerosol can (aluminium coated on the inside with epoxy phenolic resin) |
Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Spray the surface to be disinfected from a distance of 15-20 cm. Thoroughly wet surface with product for 20 seconds/m2, make sure to wet surfaces completely. Allow to take effect for at least 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe. Clothes or wipes treated with the product must be discarded in a closed container.
Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
See general directions for use.
See general directions for use.
See general directions for use.
See use-specific instructions for use.
Use adequate ventilation with an air change rate of 8 per hour or more.
Apply away from eyes and face.
Hand protection: Wear chemically resistant protective gloves.
Eye protection: Wear eye protection.
Avoid contact with eyes.
Do not breathe vapours.
Do not eat, drink or smoke when using the product.
Wash hands thoroughly after handling.
Symptoms/injuries after inhalation : May cause drowsiness or dizziness
Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
Symptoms/injuries after eye contact: Causes serious eye irritation
Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Rinse skin with water/or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor
IF SWALLOWED: Rinse mouth. Give something to drink if conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
Empty containers must be discharged as normal waste or recycled where possible.
Additional information: Handle empty containers with care because residual vapours are flammable.
Keep away from open flames, hot surfaces and sources of ignition.
Keep container tightly closed. Keep in a cool, well-ventilated place. Store at temperatures below 40°C. Protect from frost.
Shelf-life: 3 years
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129.28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.